Cerezyme

WARNINGS

Approximately 15% of patients treated and tested to date have developed IgG
antibody to Cerezyme® (imiglucerase for injection) during the first
year of therapy. Patients who developed IgG antibody did so largely within 6
months of treatment and rarely developed antibodies to Cerezyme® (imiglucerase) after
12 months of therapy. Approximately 46% of patients with detectable IgG antibodies
experienced symptoms of hypersensitivity. Patients with antibody to Cerezyme® (imiglucerase) have a higher risk of hypersensitivity reaction. Conversely, not all patients
with symptoms of hypersensitivity have detectable IgG antibody. It is suggested
that patients be monitored periodically for IgG antibody formation during the
first year of treatment.

Treatment with Cerezyme® (imiglucerase) should be approached with caution in patients
who have exhibited symptoms of hypersensitivity to the product.

Anaphylactoid reaction has been reported in less than 1% of the patient population.
Further treatment with imiglucerase should be conducted with caution. Most patients
have successfully continued therapy after a reduction in rate of infusion and
pretreatment with antihistamines and/or corticosteroids.

PRECAUTIONS

General

In less than 1% of the patient population, pulmonary hypertension and pneumonia
have also been observed during treatment with Cerezyme® (imiglucerase
for injection). Pulmonary hypertension and pneumonia are known complications
of Gaucher disease and have been observed both in patients receiving and not
receiving Cerezyme® (imiglucerase) . No causal relationship with Cerezyme® (imiglucerase) has been established. Patients with respiratory symptoms in the absence
of fever should be evaluated for the presence of pulmonary hypertension.

Therapy with Cerezyme® (imiglucerase) should be directed by physicians knowledgeable
in the management of patients with Gaucher disease.

Caution may be advisable in administration of Cerezyme® (imiglucerase) to patients
previously treated with Ceredase® (alglucerase injection) and who
have developed antibody to Ceredase® or who have exhibited symptoms
of hypersensitivity to Ceredase®.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been conducted in either animals or humans to assess the potential
effects of Cerezyme® (imiglucerase for injection) on carcinogenesis,
mutagenesis, or impairment of fertility.

Teratogenic Effects: Pregnancy Category C

Animal reproduction studies have not been conducted with Cerezyme® (imiglucerase
for injection). It is also not known whether Cerezyme® (imiglucerase) can cause
fetal harm when administered to a pregnant woman or can affect reproductive
capacity. Cerezyme® (imiglucerase) should not be administered during pregnancy except
when the indication and need are clear and the potential benefit is judged by
the physician to substantially justify the risk.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when Cerezyme® (imiglucerase for injection) is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Cerezyme® (imiglucerase for injection)
have been established in patients between 2 and 16 years of age. Use of Cerezyme® (imiglucerase) in this age group is supported by evidence from adequate and well-controlled
studies of Cerezyme® (imiglucerase) and Ceredase® (alglucerase injection) in
adults and pediatric patients, with additional data obtained from the medical
literature and from long-term post-marketing experience. Cerezyme® (imiglucerase) has
been administered to patients younger than 2 years of age, however the safety
and effectiveness in patients younger than 2 have not been established.

Last reviewed on RxList: 10/9/2008
This monograph has been modified to include the generic and brand name in many instances.